SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps available in the
United States, today reported the successful completion of the first
pilot study using a hybrid closed loop system featuring its t:slim X2™
Insulin Pump with embedded algorithms from TypeZero Technologies and
integration with Dexcom® G6 Continuous Glucose Monitoring (CGM). This
pilot study was the first of three in the National Institute of Health
(NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the
t:slim X2 Pump running the algorithm directly on the pump. The second
study is now moving forward with enrollment at seven clinical sites and
is anticipated to begin in the first quarter of 2018. The IDCL Trial is
expected to conclude with a pivotal study in 2018, and Tandem plans to
use this data in a PMA submission to the U.S. Food and Drug
Administration.

The hybrid closed loop system predicts high and low blood sugar levels
and adjusts insulin delivery accordingly throughout the day, while still
allowing the user to manually bolus for meals. In addition to basal
insulin adjustments, the system also automates correction boluses. The
hybrid closed loop software developed by TypeZero includes a series of
algorithms developed from initial research conducted at the University
of Virginia. To date, this technology has been used in more than 30
clinical studies involving more than 450 participants, with data
referenced in a number of journal articles.1

“The first successful use of the commercial version of our hybrid closed
loop system is a huge step forward, and the speed of the development
cycle for this product has been impressive for our industry,” said Kim
Blickenstaff, president and CEO of Tandem Diabetes Care. “We look
forward to starting the pivotal study later this year and continue to
prepare for a launch in the first half of 2019, subject to FDA approval.”

“We have enjoyed introducing patients to this latest advancement in
technology, featuring an easy-to-use system and an algorithm with a
successful track record in past clinical trials of improving blood
glucose control while simultaneously decreasing hypoglycemia,” said Sue
Brown, Associate Professor at the Center for Diabetes Technology at the
University of Virginia and the endocrinologist in charge of the IDCL
trials using this embedded technology. “This study was an exciting step
forward in closed-loop technology for people with diabetes.”

“Sensor accuracy is a critical component for automated insulin delivery,
and we are excited to have the first integration of Dexcom’s
next-generation G6 CGM technology in this hybrid closed loop system,”
said Steve Pacelli, Executive Vice President of Strategy and Corporate
Development at Dexcom. “We are proud to partner with Tandem in the IDCL
trial and are thrilled to see this integrated product moving forward
into multi-center studies.”

The IDCL Trial started in late 2016 and is expected to include up to 360
adults with type 1 diabetes across all of its studies. Earlier phases of
the IDCL used a Tandem insulin pump and Dexcom G5 sensor as part of a
blood glucose control system that combined these devices with a
smartphone running TypeZero’s inControl closed loop algorithms. The
latest series of studies, now using the fully-integrated system, began
with the supervised 36 to 48-hour pilot study in 5 subjects conducted at
the University of Virginia. The next study, scheduled to take place in
early 2018, will be a two-week, at-home study with enrollment at seven
centers across the United States. A pivotal trial is planned to take
place at these same centers following successful completion and review
of the two-week study.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company dedicated to improving the lives of people
with diabetes through relentless innovation and revolutionary customer
experience. The Company takes an innovative, user-centric approach to
the design, development and commercialization of products for people
with diabetes who use insulin. Tandem manufactures and sells the t:slim
X2™ Insulin Pump, the only pump capable of remote feature updates using
a personal computer, now available with Dexcom G5® Mobile CGM
integration, and the t:flex® Insulin Pump, the first pump designed for
people with greater insulin requirements. Tandem is based in San Diego,
California.

Tandem Diabetes Care and t:flex are registered trademarks, and t:slim X2
is a trademark of Tandem Diabetes Care, Inc. Dexcom, Dexcom G5 and
Dexcom G6 are registered trademarks of Dexcom, Inc. All other trademarks
are the property of their respective owners.

Forward Looking Statement

This press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the timing of anticipated enrollment,
commencement and completion of the remaining studies that comprise the
IDCL trial, whether the data from the IDCL trial will be adequate to
support a future regulatory filing by Tandem and the anticipated launch
of an integrated product in the first half of 2019. These statements are
subject to numerous risks and uncertainties, including the risk that
each of the remaining studies that comprise the IDCL trial will be
completed as currently contemplated, Dexcom’s ability to secure
regulatory approval for the Dexcom G6 CGM, and Tandem’s ability to rely
on the data from the IDCL trial to support a future regulatory filing,
as well as other risks identified in Tandem’s most recent Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other
documents that we file with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. The companies undertake no obligation to update or review any
forward-looking statement in this press release because of new
information, future events or other factors.